Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

Not Applicable

• Conditions: Simple Diverticular Disease
• Interventions: Drug: Cephalosporin + Metronidazole

• Registration Number: NCT02314013
• Lead Sponsor: Dongtan Sacred Heart Hospital

Brief Summary

The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis.

The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.

Detailed Description

All patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group.

Patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. And then the patient discharge until oral intake was tolerated.

In antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. Oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. The total duration of antibiotic treatment was an expected average 10days.

Patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and C-reactive protein), and after an expected average 6 weeks for CT. If the patients did not re-visit outpatient clinic, we checked the call.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-10
• Status Verified: 2016-04
• Primary Completion: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-16
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Right-sided colonic diverticulitis
• Uncomplicated diverticulitis

Exclusion Criteria

• Pregnancy
• Refuse to investigation
• Immunosuppressive therapy or immunologic incompetence
• Colonic diverticulitis except right-sided diverticulitis
• Complicated diverticulitis
• Disorder of psychology or cognition
• Allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cephalosporin + Metronidazole	Cephalosporin + Metronidazole	intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)

Primary Outcome Measures

Name	Time	Method
Treatment Failure	4-6 weeks	advancement or recurrence diverticulitis at the same site.

Secondary Outcome Measures

Name	Time	Method
total cost of hospitalization for diverticulitis	up to 2 weeks	length of hospital stay
length of hospital stay at first admission for diverticulitis	up to 2 weeks

Trial Locations

Locations (1)

Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine; 🇰🇷 Hwaseong-Si, Gyeonggi-Do, Korea, Republic of